Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 910-853-9 | CAS number: 8011-63-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with Good laboratory Practice and internationally accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- calcium tetracopper(2+) dioxocopperbis(olate) hexahydroxide sulfate
- EC Number:
- 910-853-9
- Cas Number:
- 8011-63-0
- Molecular formula:
- Ca3Cu4H6O22S4.nH2O where n = 1 to 6
- IUPAC Name:
- calcium tetracopper(2+) dioxocopperbis(olate) hexahydroxide sulfate
- Details on test material:
- - Name of test material (as cited in study report): Bordeaux Mixture
- Composition of test material, percentage of components: 58% w/w as copper
- Lot/batch No.: Not stated
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Young adult males weighing 1.7 to 2.0 kg were housed singly and acclimatised prior to dosing.
Test system
- Type of coverage:
- other: See Details on study design
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams.
- Test material was moistened with water prior to administration. - Duration of treatment / exposure:
- Four hours.
- Observation period:
- 72 hours.
- Number of animals:
- Three.
- Details on study design:
- On the day prior to application, an area on the dorsal area of the trunk of each animal was clipped free of fur. The following day, 0.5 g of test material was applied to the intact skin on each rabbit under a gauze patch 2.5 x 2.5 cm in size. The patch was covered with tape and the trunk of the animal was wrapped with an elastic bandage. After 4 hours, the dressings were removed and the skin wiped with dampened tissues to remove any residual test substance. Animals were examined for signs of irritation after 1, 24, 48 and 72 hours and effects scored according to Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- No erythema or oedema was recorded in any animal at any time.
- Other effects:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Classification according to Directive 67/548/EEC: Not classified.
Classification according to CLP/GHS: Not classified. - Executive summary:
A GLP-compliant study was carried out with Bordeaux Mixture in accordance with the requirements of OECD 404 without significant deviation. Test materialwas moistened with water prior to administration. Three young adult male New Zealand white rabbits weighing 1.7 to 2.0 kg were housed singly and acclimatised prior to dosing. On the day prior to application, an area on the dorsal area of the trunk of each animal was clipped free of fur. The following day, 0.5 g of test material was applied to the intact skin on each rabbit under a gauze patch 2.5 x 2.5 cm in size. The patch was covered with tape and the trunk of the animal was wrapped with an elastic bandage. After 4 hours, the dressings were removed and the skin wiped with dampened tissues to remove any residual test substance. Animals were examined for signs of irritation after 1, 24, 48 and 72 hours and effects scored according to Draize.
No erythema or oedema was recorded in any animal at any time. On this basis, Bordeaux Mixure is not classified as a skin irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
